EP0440385A2 - Elektrochirurgisches Gerät für die endoskopische retrograde Sphinkterotomie - Google Patents

Elektrochirurgisches Gerät für die endoskopische retrograde Sphinkterotomie Download PDF

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Publication number
EP0440385A2
EP0440385A2 EP91300600A EP91300600A EP0440385A2 EP 0440385 A2 EP0440385 A2 EP 0440385A2 EP 91300600 A EP91300600 A EP 91300600A EP 91300600 A EP91300600 A EP 91300600A EP 0440385 A2 EP0440385 A2 EP 0440385A2
Authority
EP
European Patent Office
Prior art keywords
electrosurgical instrument
lumen
conductor
flexible
distal end
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP91300600A
Other languages
English (en)
French (fr)
Other versions
EP0440385A3 (en
Inventor
Mark A. Rydell
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Everest Medical Corp
Original Assignee
Everest Medical Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Everest Medical Corp filed Critical Everest Medical Corp
Publication of EP0440385A2 publication Critical patent/EP0440385A2/de
Publication of EP0440385A3 publication Critical patent/EP0440385A3/en
Withdrawn legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1402—Probes for open surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00553—Sphincter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1405—Electrodes having a specific shape
    • A61B2018/1407—Loop
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M3/00—Medical syringes, e.g. enemata; Irrigators
    • A61M3/02—Enemata; Irrigators
    • A61M3/0279—Cannula; Nozzles; Tips; their connection means

Definitions

  • This invention relates generally to electrosurgical apparatus, and more particularly to a catheter-based, bipolar electrosurgical device which can be passed through an endoscope into the duodenum to the site of the papilla of Vater and which can be deployed to cut the sphincter of Oddi to allow passage of gallstones from the common bile duct into the duodenum.
  • a side-viewing endoscope is passed through the esophagus into the stomach and from there through the pyloric sphincter into the duodenum.
  • the distal end of the endoscope is made to approach the papilla of Vater and, when so positioned, a cannula is passed through the endoscope and through the sphincter of Oddi into the common bile duct.
  • a contrast fluid may be injected so that any gallstones can be viewed fluoroscopically and their size evaluated.
  • a stone is deemed to be too large to pass through the sphincter of Oddi even when enlarged, the sphincterotomy procedure is terminated and the patient at that point becomes an abdominal surgery candidate.
  • an electrosurgical instrument referred to as a sphinctertome or papillatome is made to pass through a side port in the endoscope and through the sphincter of Oddi.
  • the instrument is used to cut the sphincter of Oddi to effectively allow it to expand and pass gallstones of a size too large to pass through that sphincter normally.
  • Electrosurgical sphinctertomes of the prior art have been monopolar in nature.
  • it would typically comprise an elongated tube having a proximal end, a distal end and a lumen extending between the two ends.
  • a small aperture is formed a short distance proximal of the distal end and a conductive wire is routed through the lumen of the tube, out the aperture and then anchored proximate the distal tip of the tube.
  • This wire would be electrically coupled to an electrosurgical generator whose other terminal connects to an indifferent electrode called a patient plate placed in electrical contact with the patient's buttocks.
  • the tip portion of the sphinctertome becomes bowed and when the voltage is applied between the wire and the patient plate, a current flows from the wire through contacting tissue and from there through a path of least resistance to the patient plate.
  • the present invention comprises a bipolar sphinctertome.
  • the device itself has an elongated flexible tubular catheter body with a proximal end, a distal end and at least one lumen extending the length of the catheter.
  • a flexible conductive segment normally coaxially aligned with the tube.
  • an aperture which extends through the side wall of the tube. Passing through the lumen from the proximal end are first and second conductors, one being electrically joined to the flexible conductive segment and the other passing from the lumen through the aperture to the exterior and thence parallel to the flexible conductive segment to an anchoring point at the distal end portion of the catheter body.
  • a handle member Located at the proximal end of the tubular catheter is a handle member having a finger-operated slide coupled to the conductor whose distal end portion passes through the aperture in the catheter body. By manipulating the slide, the distal end portion of the catheter may be made to bow.
  • the flexible conductive segment and the length of wire extending parallel thereto form a bipolar electrode pair.
  • bipolar sphinctertome of the present invention allows better control over the depth of tissue destruction which is much less than is the case when a monopolar sphinctertome is employed. Also, since the current path is concentrated to the area of the surgery, greatly improved hemostasis can be achieved. Moreover, incidences of pancreatitis occasioned by errant currents seeking a return to the patient plate is obviated.
  • a further advantage of the bipolar sphinctertome of the present invention resides in the fact that the area of the flexible conductive segment and that of the active wire electrode which extends parallel to it in passing into the sphincter of Oddi, remains substantially constant. As such, better control can be maintained over the power level delivered to the site of the surgery.
  • a sphinctertome to be used during an endoscopic retrograde sphincterotomy to enlarge the opening surrounded by the sphincter of Oddi so that gallstones of a predetermined size or less may more readily pass from the common bile duct into the duodenum. It is seen to comprise an elongated flexible tubular member 12 having a proximal end 14 and a distal end 16 with at least one lumen 18 extending between the proximal end distal ends. Coaxially disposed a short distance proximal of the distal end 16 of the tube 18 is a flexible conductive segment shown enclosed by brackets 20.
  • the flexible conductive segment 20 comprises a helically wound wire spring 22 to which an electrical conductor 24 connects, that conductor extending back through the lumen 18 to the proximal end of the tube 12 and there beyond. Also extending through the lumen 18 and insulated from the conductor 24 is a stainless steel wire 25 having an outside diameter of about 0.012 inch.
  • the wire 26 exits the tube 12 via a small lateral aperture 28 formed through the wall of the tube and then extends generally parallel to the flexible conductive segment 20 until being mechanically attached at point 30 to the wall of the plastic tube 12.
  • a further aperture or port 32 extends through the wall of the tube 12 at its distal end 16 allowing a flushing liquid or a contrast liquid to be injected into the body proximate the surgical site if desired.
  • a two-piece handle segment coupled to the proximal end 14 of the elongated plastic tubular catheter body 12 is a two-piece handle segment, indicated generally by numeral 34.
  • the forward or more distal segment of the two-piece handle is identified by numeral 36 and is seen to be generally tubular in form, having a central bore 38 extending the length thereof.
  • a flexible, elastomeric disk 40 Positioned within the bore 38 is a flexible, elastomeric disk 40 positioned transverse to the longitudinal axis of the bore 38.
  • a cruciform self-sealing slit 42 ( Figure 4) which permits the conductors 24 and 26 to pass therethrough but which forms a liquid-tight seal thereabout.
  • a tubular stem 44 Projecting laterally from the handle segment 36 and integrally molded therewith is a tubular stem 44 having an internal Luer fitting 46 formed on the end thereof whereby the tubular stem 44 may be connected to a syringe or other source of a flushing or contrast liquid (not shown).
  • the lumen of the stem 44 intersects with the bore 38 of the handle portion 36 and that bore, in turn, is in fluid communication with the lumen 18 of the elongated flexible plastic tubular member 12. As such, a liquid introduced through the port 46 may be made to flow through the tube 12 and out its distal ejection port 32.
  • the second segment of the two-piece handle is identified by numeral 48 and may be generally cylindrical in form having a distal nose portion 50 of a reduced diameter as compared to its main body portion 52.
  • Member 48 like segment 36, may preferably be formed in a plastic molding operation from any one of a number of medical grade plastics.
  • the nose portion 50 is adapted to be inserted into the bore 38 of the handle segment 36 and when so inserted, may be held in place by a set screw (not shown) which fits into a threaded bore extending transverse to the bore 38.
  • the set screw is provided with a thumb wheel 54 to facilitate its loosening and tightening.
  • a longitudinal slot 56 Formed through the cylindrical body of the handle segment 48 is a longitudinal slot 56. With reference to the bottom view of Figure 3, it can be seen that a pin with an enlarged head 58 passes transversely through the slot 56 and into a slide member 60 having finger holes 62 and 64 formed therethrough.
  • a thumb-receiving ring 66 is integrally molded with or otherwise affixed to the body member 52 allowing the surgeon to readily grasp the handle portion and manipulate the slide plate 60 in the proximal or distal direction as indicated by the doubled-headed arrow 68 by inserting the forefinger and the index fingers through the openings 62 and 64.
  • the conductor 26 has a cylindrical, conductive contact 70 attached to its proximal end which is fitted into a recess formed on the underside of the slide 60 such that the wire 26 will move axially with the slide plate 60.
  • An electrical connector pin 72 passes through the side wall of the cylindrical member 52 and into the slot 56.
  • a wire or cable 78 connects to that connector ping 76 to a terminal of an electrosurgical generator (not shown).
  • the conductor 24 also connects to a contact also passing through the wall of the slot 56 and a conductor 80 joins thereto and leads to the other output terminal of the electrosurgical generator.
  • An electrosurgical generator suitable for use with the sphinctertome of the present invention may be that described in the Stasz et al patent application Serial No. 07/254,203, allowed October 6, 1989, and entitled "Electrosurgical Generator" and assigned to the assignee of the present invention.
  • Figure 2 is an illustration of the distal end portion of the sphinctertome of Figure 1 when the slide plate 60 is pulled in the proximal direction to apply a tension force on the conductor 26.
  • the conductive segment 22 of the device being flexible, allows the instrument to bow in the manner shown.
  • an RF voltage from the generator can be applied when the surgeon depresses a foot switch (not shown) current flow between the cutting wire 26 and the flexible conductive return electrode 22 effects cutting of cell tissue present between the cutting wire 26 and the indifferent electrode.
  • Figure 5 illustrates an arrangement where the elongated flexible plastic tube 12 includes a pair of lumens 82 and 84 for maintaining the wires 24 and 26 insulated from one another along their length.
  • the conductors 24 and 26 may comprises bare wires whereas in the arrangement shown in Figures 1 and 2 involving a single lumen tube, the wires 24 and 26 must be coated with an insulating layer to prevent short circuiting. Flushing liquid is introduced only into the lumen to which aperture 32 joins.
  • Figure 6 illustrates an alternative arrangement where the flexible conductive segment 20 located near the distal end of the tubular body 12 comprises a conductive coating 86 on the exterior of tube 12 rather than a helically wound wire spring element like member 22 in Figure 1.
  • the distal end portion is formed of a composite of a conductive silicone layer 88 bonded to a non-conductive silicone layer 90, the conductor 24 being electrically joined to the conductive silicone layer 88 internal to the catheter body.
  • Figure 8 is still another alternative arrangement in which a bilumen tube 12 is employed with one of the lumens being filled with a conductive polymer at its distal end to function as the return electrode as at 92. The side wall of the tube 12 is then ground away to expose the conductive polymer.
  • the liver is identified by numeral 100 and the hepatic duct by numeral 102.
  • the gallbladder is identified by numeral 104 and is sectioned to reveal a number of gallstones as at 106, the stones varying in both size and shape.
  • the cystic duct 108 connects the gallbladder 104 to the common bile duct, which is also sectioned open to reveal the presence of further stones 106 therein.
  • the common bile duct leads to the sphincter of Oddi 112 located at the duodenal papilla 114 sometimes referred to as the papilla Vater.
  • the duodenum is identified by numeral 116 and the pancreatic duct by numeral 118.
  • gallstones When gallstones form because of an excess of cholesterol in the bile and/or the absorption of too much bile acids from the bile, they may pass from the gallbladder and down the common bile duct into the duodenum without problem provided the stones are sufficiently small. Occasionally, however, the gallstones within the gallbladder develop to a size where they may block the normal flow of bile during digestion of fatty foods, resulting in a blockage of the cystic duct 108 or the common bile duct 110.
  • the sphincter of Oddi comprises a restriction and is a location where a larger stone may not be able to pass.
  • a side viewing endoscope is inserted down the patient's esophagus through the stomach and into the duodenum. While viewing the surgical site through a fiber optic rod, the surgeon may first pass a small diameter cannula through a side port of the endoscope to gently lift the tissue flap covering the papilla of Vater at 114 and then it is advanced into the common bile duct.
  • a suitable contrast fluid such as Hypaque® meglumine 60%, may then be injected through the cannula whereby the condition of the common bile duct and the stone content thereof can be assessed.
  • the elongated tube portion 12 of the sphinctertome 10 is routed through the endoscope and the rounded distal tip 16 is advanced through the sphincter.
  • the endoscope is not shown so that the sphinctertome of the present invention can better be viewed.
  • the tension on the cutting wire 26 is nil and the distal end portion of the sphinctertome remains relatively straight.
  • the surgeon may next pull back in the proximal direction on the slide bar 60 and, in doing so, will apply a tensioning force to the cutting wire 26 causing the distal end portion to bow as illustrated in Figure 2.
  • the RF voltage provided by the electrosurgical generator is applied between the cutting wire 26 to the flexible conductive segment 26 which forms a bipolar electrode pair.
  • the tissue comprising the sphincter of Oddi will at this time be in contact with the wire 26 and the return electrode, the tissue will be cut at its point of contact with the wire 26 to thereby enlarge the opening defined by the sphincter of Oddi.
  • substantially larger stones than could normally pass will find their way out through the enlarged sphincter into the duodenum and will then pass through the remainder of the digestive tract.
  • the cutting is accompanied by coagulation, thereby significantly reducing the loss of blood.
  • the electrode configuration is bipolar, the current path is only through tissue abutting the cutting wire 26 and the return electrode 22.
  • the tendency for substantial electrical currents to flow through the conductive contrast fluid or other body fluids contained in the pancreatic duct is eliminated and the likelihood of a subsequent inflammation of the pancreas often accompanying monopolar sphincterotomy is markedly reduced.

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Otolaryngology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Plasma & Fusion (AREA)
  • Physics & Mathematics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)
EP19910300600 1990-02-02 1991-01-25 Electrosurgical instrument for conducting endoscopic retrograde sphicterotomy Withdrawn EP0440385A3 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US474481 1983-03-11
US07/474,481 US5035696A (en) 1990-02-02 1990-02-02 Electrosurgical instrument for conducting endoscopic retrograde sphincterotomy

Publications (2)

Publication Number Publication Date
EP0440385A2 true EP0440385A2 (de) 1991-08-07
EP0440385A3 EP0440385A3 (en) 1991-12-11

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Application Number Title Priority Date Filing Date
EP19910300600 Withdrawn EP0440385A3 (en) 1990-02-02 1991-01-25 Electrosurgical instrument for conducting endoscopic retrograde sphicterotomy

Country Status (4)

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US (1) US5035696A (de)
EP (1) EP0440385A3 (de)
JP (1) JPH0773583B2 (de)
CA (1) CA2034823A1 (de)

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US8827992B2 (en) 2010-03-26 2014-09-09 Aesculap Ag Impedance mediated control of power delivery for electrosurgery
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US5035696A (en) 1991-07-30
JPH0773583B2 (ja) 1995-08-09
JPH0751288A (ja) 1995-02-28
CA2034823A1 (en) 1991-08-03
EP0440385A3 (en) 1991-12-11

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